Top Stories
Shire plans to establish a 550,000-square-foot campus that will focus on innovation in rare diseases and highly specialized conditions.
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Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.
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Industry News
Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor.
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FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations.
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EXPERT INTERVIEW
Francis Flanagan, associate principal scientist at Merck, sat down with Pharmaceutical Technology to discuss using minitablets in pharmaceutical manufacturing.
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Watch our multiplexed peptide quantitation webinar on demand!
Dr. Eric Kuhn, Research Scientist at the Broad Institute, presents his research on the development and performance characterization of an automated immunoaffinity workflow up to multiplex levels of 172. He also details the application of a 120-plex iMRM assay to identify biomarkers of cardiovascular disease.
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Supplier News
Patheon adds API manufacturing capacity with acquisition of Roche's Florence, SC facility.
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Saneca Pharma has secured an agreement with Italian pharmaceutical company Menarini Group to deliver controlled-release pellets for one of its products.
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Bio/Pharma News
The acquisition boosts Allergan's CNS R&D pipeline and adds development programs focused on treatment for Alzheimer's disease.
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Mylan signed a sub-license agreement with the Medicines Patent Pool to develop a generic version of daclatasvir to market in developing countries.
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Connect with top suppliers to the pharma and medical device industry at PACK EXPO East in Philadelphia, February 27 to March 1, 2017. You'll discover new solutions for enhancing safety, security and quality from 400+ exhibitors. Explore 100,000 nsf of packaging innovations and machinery in action. Exchange ideas with 7,000 peers. And gain insights from the Healthcare Packaging and Processing Conference. Register today at  packexpoeast.com! |
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Regulatory News
Wockhardt Limited received a warning letter from FDA for CGMP violations.
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FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.
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MANUFACTURING
Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.
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PEER-REVIEWED RESEARCH
This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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VIEWPOINTS
CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.
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FORMULATION
Industry experts discuss key considerations in the development of orally disintegrating tablets.
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Events
December 7–8, 2016
January 9–13, 2017
May 16–18, 2017
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REFERENCE BOOKS |
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A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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